NCT07757386

Brief Summary

The goal of this trial was to learn whether the MelaMEd online training program could improve doctors' skills in the early detection and management of melanoma, the most aggressive type of skin cancer. The participants were primary care physicians, including general practitioners, general practice trainees, and pediatricians. The main questions were: Did the training improve doctors' ability to identify skin lesions that might be melanoma? Did the training improve their knowledge of melanoma prevention, diagnosis, and management? Did the training help doctors make better decisions about referring patients to a dermatologist? Participants first completed an online questionnaire. It included questions about melanoma and images of skin lesions. Participants then completed the MelaMEd online training course. After the training, participants completed a second questionnaire with the same main questions. They also answered questions about their confidence in managing melanoma and their experience with the course. Researchers compared each participant's answers before and after the training. There was no separate comparison group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,531

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

1.6 years

First QC Date

July 16, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

MelaMEdGeneral PractitionersPrimary Care PhysiciansMedical EducationE-LearningMelanoma DetectionDiagnostic AccuracySkin Lesion TriageContinuing Medical Education

Outcome Measures

Primary Outcomes (3)

  • Change in Melanoma Knowledge After MelaMEd Training

    Melanoma knowledge was assessed using seven multiple-choice questions covering ultraviolet radiation, complete skin examination, the ABCDE rule, the EFG rule, the Ugly Duckling sign, dermoscopy, and Breslow thickness. For each question, the percentage of participants selecting the correct answer was calculated before and after training using matched responses. Higher percentages indicate better melanoma knowledge.

    Pre-training baseline and post-training assessment within 10 days of completion of the online course

  • Change in Diagnostic Performance Across 10 Skin Lesion Cases

    Diagnostic performance was assessed using 10 clinical images of melanocytic and non-melanocytic skin lesions. For each case, participants classified the lesion as benign or malignant and selected the most likely diagnosis from four options. The percentages of correct benign or malignant classifications and correct diagnoses were calculated before and after training using matched responses. Pooled sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy were also calculated. Higher values indicate better diagnostic performance.

    Pre-training baseline and post-training assessment within 10 days of completion of the online course

  • Change in Dermatology Referral Decisions for Skin Lesions

    Using the same 10 clinical cases, participants indicated whether the person should be referred to a dermatologist for specialist assessment and possible excision. For each case, the percentage of participants selecting referral was calculated before and after training using matched responses. Changes were interpreted according to the reference diagnosis, with the aim of increasing referral of malignant lesions and reducing unnecessary referral of benign lesions.

    Pre-training baseline and post-training assessment within 10 days of completion of the online course

Secondary Outcomes (2)

  • Change in Self-Reported Confidence in Melanoma Prevention and Detection

    Pre-training baseline and post-training assessment within 10 days of completion of the online course

  • Participant Satisfaction and Perceived Usefulness of the MelaMEd Training

    Post-training assessment within 10 days of completion of the online course

Study Arms (1)

MelaMEd Online Training

EXPERIMENTAL

Participants received the MelaMEd asynchronous online educational program, including video lessons, interactive clinical cases, and access to the MelaMEd multimedia platform. Knowledge of melanoma, diagnostic performance, referral decisions, and self-reported confidence were assessed before and after the training. No control or comparison arm was included.

Behavioral: MelaMEd Online Training Program

Interventions

The intervention was a free, self-paced asynchronous e-learning course titled "Early Diagnosis and Management of the Therapeutic Diagnostic Pathway of Melanoma," integrated with the MelaMEd multimedia platform. The course included video lectures and interactive clinical cases covering melanoma risk factors, sun exposure and photoprotection, skin examination, clinical recognition rules such as the ABCDE rule, the EFG rule, and the "Ugly Duckling" sign, histopathological diagnosis, surgical and medical treatment, staging, prognosis, and referral decision-making. The linked MelaMEd platform provided clinical, dermoscopic, and histological images, interactive educational resources, and access to guidelines and scientific literature.

MelaMEd Online Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Licensed general practitioners, general practitioners in training, or pediatricians working in the healthcare system areas served by participating Italian Melanoma Intergroup centers.
  • Voluntary agreement to participate in the study evaluation.
  • Confirmation that the participant had read and understood the information on personal data processing.
  • Authorization for the processing of personal data in accordance with European Union Regulation 2016/679.

You may not qualify if:

  • Individuals who did not authorize the processing of their personal data could access the MelaMEd educational course and platform but were not included in the evaluation of the training program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Dermatology and Dermosurgery Unit, San Giuseppe Moscati Hospital

Avellino, Campania, 83100, Italy

Location

Divisione di Dermatologia Cesena/Forlì AUSL Romagna e Dipartimento di Medicina e Chirurgia, Università di Bologna

Cesena, Emilia-Romagna, 47521, Italy

Location

Section of Dermatology and Infectious Diseases, University of Ferrara

Ferrara, Emilia-Romagna, 44121, Italy

Location

SC Dermatologia, Dipartimento di Medicina e Chirurgia, Università di Parma, Parma

Parma, Emilia-Romagna, 43126, Italy

Location

Istituto Dermopatico dell'Immacolata (IDI)-IRCCS, Roma

Rome, Lazio, 00167, Italy

Location

Unità di Dermatologia, ASST Papa Giovanni XXIII Ospedale di Bergamo, Bergamo

Bergamo, Lombardy, 24127, Italy

Location

Unità di Dermatologia, Azienda Socio Sanitaria Territoriale (ASST) Lecco, Ospedale Alessandro Manzoni, Lecco

Lecco, Lombardy, 23900, Italy

Location

Clinica Dermatologica, Fondazione IRCCS Policlinico San Matteo Pavia, Università degli Studi di Pavia, Pavia

Pavia, Lombardy, 27100, Italy

Location

Melanoma Skin Centre, ASST dei Sette Laghi, Ospedale di Circolo e Fondazione Macchi

Varese, Lombardy, 21100, Italy

Location

Dipartimento di Medicina, Chirurgia e Farmacia, Università di Sassari, Sassari

Sassari, Sardinia, 07100, Italy

Location

Related Links

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ignazio Stanganelli, MD

    Skin Cancer Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: All participants were assigned to the same MelaMEd educational intervention. The study used a single-group before-and-after design, with no control or comparison arm. Training effectiveness was assessed by comparing available paired responses to questionnaires completed before and after the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Biostatistician

Study Record Dates

First Submitted

July 16, 2026

First Posted

August 11, 2026

Study Start

June 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant-level data underlying the tables and analyses reported in the primary publication will be shared. The dataset will include the participant-level professional characteristics and questionnaire responses used in the reported analyses. Direct identifiers, contact details, workplace information, and any variables that could reasonably permit participant re-identification will not be shared. The final dataset and accompanying documentation will be deposited in the authors' institutional Zenodo repository after acceptance of the primary manuscript. The repository DOI will be added to the study record when available.

Shared Documents
STUDY PROTOCOL
Time Frame
The data will become available after acceptance of the primary manuscript and deposition of the final dataset in Zenodo. They will remain available without a planned end date.
Access Criteria
The de-identified dataset will be publicly available through Zenodo under the terms of the license assigned to the repository record.

Locations